NCT00320255

A Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer

A Randomized, Double-blind, Placebo-controlled Study of Apixaban for the Prevention of Thromboembolic Events in Patients Undergoing Treatment for Advanced Cancer: A Phase 2 Pilot Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to learn whether apixaban is well-tolerated and acceptable as anticoagulant therapy, when administered to patients with advanced or metastatic cancer and at increased risk for venous thromboembolic events. Demonstration of a favorable benefit:risk profile could lead to significant reduction in this serious and sometimes fatal complication of ongoing cancer and its treatment.

Conditions

• Thrombosis
• Cancer
• Pulmonary Embolism

Interventions

Type	Name	Description
DRUG	Apixaban	Oral tablets administered once daily in 5-, 10-, or 20-mg dose
DRUG	Placebo	Oral tablets administered once daily

Timeline

• Start date: 2006-06-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2006-05-03
• Last updated: 2016-08-16
• Results posted: 2016-08-16

Locations

14 sites across 2 countries: United States, Canada